Covid19Phase 3NCT04558463
The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19
A Phase 3 study testing Favipiravir and Oseltamivir 75mg in people with Covid19, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Favipiravir and Oseltamivir 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Apr 2020to 30 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged 18-75 years old
- Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR COVID-19 IgM/IgG rapid test
- No history of favipiravir or oseltamivir allergy
- Consented to participate in the trial.
Who cannot join
- Pregnant women
- Breastfeeding mother
- Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times from baseline level
- Reduced kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min OR serum creatinine > 2 mg/dL
- Patients with history of heart failure
- Tuberculosis infection that was treated with pyrazinamide
- Asthma that was treated with theophylline
- Type 2 diabetes that was treated with repaglinid
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Referral Hospital
Jakarta, DKI Jakarta, 10430
Dante S Harbuwono, MD, PhD, +62213907703, dante.saksono@ui.ac.id
About this study
Official title: The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
Read the detailed description
This open-label trial aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
- Conditions
- Covid19
- Being tested
- Favipiravir, Oseltamivir 75mg
- Keywords
- COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called Avigan® (favipiravir)
The favipiravir group received loading dose of 1600 mg twice a day (3200 mg/day) on the first day and continued with 600 mg twice a day (1200 mg/day) for the next 2nd - 7th day in addition to the standard therapy.
Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
Oseltamivir 75mgDrug
Also called Oseltamivir
The oseltamivir group was given twice a day of 75 mg of oseltamivir (150 mg/day) for 7 days in addition to standard therapy
Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir | Experimental | The favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy Receives: Drug: Favipiravir |
| Oseltamivir | Active comparator | The oseltamivir group was given oseltamivir for 7 days. Receives: Drug: Oseltamivir 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical radiologic changes
Changes of lung infiltrate in chest xray AND/OR GGO in chest CT scan after 14 days of follow up period This outcome measured will displayed as improvement/no changes/deterioration of radiologic examination results
Measured: 14 days
Percentage of RT-PCR test convertion
Convertion of RT-PCR swab result from positive to negative at the end of 14 days study follow up This outcome measured will displayed as convertion OR no conversion
Measured: 14 days
Secondary outcomes (3)
Adverse event
Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme >3x normal limit
Measured: 14 days
Hospital length of stay (LOS)
Days of hospitalization from the first dose of intervention
Measured: 14 days
Case Fatality Rate (CFR)
CFR is calculated from mortality rate during hospital admission
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start16 Apr 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Dante Saksono Harbuwono, Sp.PD, PhD, Universitas Indonesia
- Investigators
- Dante S Harbuwono, MD, PhD, Principal investigator, Head of Division Endocrinology, Department of Internal Medicine, FMUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558463
- Sponsor's protocol ID
- 20-04-0455
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial
- ClinicalTrials.gov ID
- NCT04558463
- Acronym / sponsor ID
- 20-04-0455
- Conditions
- Covid19
- Keywords
- COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
Detailed description
This open-label trial aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy
| Arm | Type | Receives |
|---|---|---|
| Favipiravir | Experimental | Drug: FavipiravirThe favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy |
| Oseltamivir | Active comparator | Drug: Oseltamivir 75mgThe oseltamivir group was given oseltamivir for 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients aged 18-75 years old
- Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR COVID-19 IgM/IgG rapid test
- No history of favipiravir or oseltamivir allergy
- Consented to participate in the trial.
Key exclusion criteria (8 listed)
- Pregnant women
- Breastfeeding mother
- Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times from baseline level
- Reduced kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min OR serum creatinine > 2 mg/dL
- Patients with history of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FavipiravirAlso: Avigan® (favipiravir)The favipiravir group received loading dose of 1600 mg twice a day (3200 mg/day) on the first day and continued with 600 mg twice a day (1200 mg/day) for the next 2nd - 7th day in addition to the standard therapy. Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug | Drug | Favipiravir |
| Oseltamivir 75mgAlso: OseltamivirThe oseltamivir group was given twice a day of 75 mg of oseltamivir (150 mg/day) for 7 days in addition to standard therapy Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug | Drug | Oseltamivir |
Primary outcome
Clinical radiologic changes
Time frame: 14 days
Changes of lung infiltrate in chest xray AND/OR GGO in chest CT scan after 14 days of follow up period This outcome measured will displayed as improvement/no changes/deterioration of radiologic examination results
Percentage of RT-PCR test convertion
Time frame: 14 days
Convertion of RT-PCR swab result from positive to negative at the end of 14 days study follow up This outcome measured will displayed as convertion OR no conversion
3 secondary outcomes
Adverse event
Time frame: 14 days
Hospital length of stay (LOS)
Time frame: 14 days
Case Fatality Rate (CFR)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dante S Harbuwono, MD, PhD principal investigator
Head of Division Endocrinology, Department of Internal Medicine, FMUI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Favipiravir and Oseltamivir 75mg in people with Covid19, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dante S Harbuwono, MD, PhD (+62213907703, dante.saksono@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical radiologic changes (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.